Intervention - Subjects will be randomized to 2 groups Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine) Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 hour Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h * Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test at regular intervals. * Stopping rule-Development of sepsis, worsening of Liver functions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Proportion of patients with normalization of LFT (Liver Function Test) in both groups.
Normalization of LFT (Liver Function Test) which is defined as Total bilirubin within normal limits.
Time frame: 20 days
Improvement in of Histology.
Improvement is defined as decrease in inflammation, decrease in cholestasis.
Time frame: 20 days
Improvement in CBC profile
Improvement is defined normalization of CBC profile.
Time frame: 20 days
Improvement in coagulation profile
Improvement is defined normalization of Coagulation profile.
Time frame: 20 days
Improvement in KFT profile
Improvement is defined normalization of KFT profile.
Time frame: 20 days
Proportion of patients develop adverse effects in both groups.
Time frame: 20 days
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